G/SPS/N/EU/338  
 
7 August 2019  
(19-5135) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved:   
2. Agency responsible:  European Commission, Health and Food Safety 
Directorate -General  
3. Products covered (provide tariff item nu mber(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Food supplements based on rice fermented with red yeast Monascus 
purpureus  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Commission Regulation amending Regulation (EC) 
1881/2006 as regards maximum levels of citrinin in food supplements based on rice 
fermented with red yeast Monascus purpureus  (Text with EEA relevance) . Language(s):  
English . Number of pages:  3+1 
https://members.wto.org/crnattachments/2019/SPS/EEC/19_4234_00_e.pdf  
https://members.wto.org/crnattachments/2019/SPS/EEC/19_4234_01_e.pdf  
6. Description of content:  The draft Regulation establishes a maximum level of citrinine 
in food supplements based on rice fermented with red yeast Monascus purpureus.  
7. Objective  and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage from pests.   
8. Is there a relevant international standard? If so, identify the standar d: 
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) :  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   G/SPS/N/EU/338  
 
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  9. Other relevant documents and language(s) in which these are available:   
The document is available in all Union languages.   
10. Proposed date of adoption (dd/mm/yy) : november 2019  
Proposed date of publication (dd/mm/yy) : november 2019  
11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) : 20 days after its publication in the Official Journal of the European 
Union. Date of entry into appli cation: 1 April 2020.  
[ ] Trade facilitating measure   
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 6 October 2019  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address 
(if available) of other body:   
European Commission  
DG Health and Food Safety, Unit D2 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(3 2 2) 295  4263 
Fax: +(32 2) 299  8090 
E-mail: sps@ec.europa.eu  
13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
European Commission  
DG Health and Food Safety, Unit D2 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 295  4263 
Fax: +(32 2) 299  8090 
E-mail: sps@ec.europa.eu